Be it Enacted by the Senate and House of Representatives in General Court convened:

1 New Subdivision; Prescription Drug Discount Prohibition. Amend RSA 161-L by inserting after section 7 the following new subdivision:

Prescription Drug Discount Prohibition

161-L:8 Prescription Drug Discount Prohibition; Exceptions.

I.(a) Except as provided in paragraph III, a person who manufactures a prescription drug shall not offer a discount, repayment, product voucher, or other reduction in an individual's out-of-pocket expenses associated with his or her health insurance, health care service plan, or other health coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individual's health insurance, health care service plan, or other health coverage on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administration's (FDA) "Approved Drug Products with Therapeutic Equivalence Evaluations."

(b) The prohibition in subparagraph (a) shall not apply to a branded prescription drug, until the time that the first drug designated in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" as therapeutically equivalent to that branded prescription drug has been nationally available for 3 calendar months.

II. Except as provided in paragraph IV, a person who manufactures a prescription drug shall not offer a discount, repayment, product voucher, or other reduction in the individual's out-of-pocket expenses associated with his or her health insurance, health care service plan, or other health coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are contained in products regulated by the FDA, are available without prescription at a lower cost, and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.

III. The prohibitions in paragraphs I and II shall not apply to any of the following:

(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patient's behalf for a prescription drug required under a FDA Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.

(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.

(c) The individual has completed any applicable step therapy or prior authorization requirements for the branded prescription drug as mandated by the individual's health insurer, health care service plan, or other health coverage.

(d) A discount, repayment, product voucher, or other reduction in an individual's out-of-pocket expenses is not associated with his or her health insurance, health care service plan, or other health coverage.

(e) Rebates received by a state agency.

IV.(a) This subdivision shall not prohibit an entity, including an entity that manufactures prescription drugs or a patient assistance program that is solely funded by one or more manufacturers, from offering a pharmaceutical product free of any cost, if the product is free of cost to both the patient and his or her health insurer, health care service plan, or other health coverage.

(b)(1) This subdivision shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.

(2) For purposes of this section, "independent charity patient assistance program" means a program that meets all of the following requirements:

(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.

(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturer's funding and the beneficiary.

(C) Assistance is awarded without regard to the pharmaceutical manufacturer's interest and without regard to the beneficiary's choice of product, provider, practitioner, supplier, health insurance, health care service plan, or other health coverage.

(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.

This bill prohibits drug manufacturers from offering coupons or discounts to cover insurance copayments or deductibles. The Insurance Department states this bill may have an impact on reducing utilization of higher priced drugs. If this were to occur, there could be an impact on claim costs which would impact premiums and premium tax revenue. The Department is not able to estimate the impact this would have on state general fund revenue or county and local expenditures.

The Department of Administrative Services assumes the impact to the State Health Benefit Plan would be minimal, if any, due to the State Plan's existing benefit plan with a low copay structure. The Department indicates it is unclear how the bill would impact rebates collected by the State Plan's Pharmacy Benefit Manager which are passed through to the State.

The Department of Health and Human Services indicates rebates and related pharmacy activities in the Medicaid program are regulated by the federal anti-kickback law (42 USC Section 1320a-7b(b)). This makes it illegal to offer any type of payment that might persuade a person to purchase something that federal healthcare programs, including Medicare and Medicaid, pay for. Although rebates, discounts, coupons and similar actions related to the Medicaid program are governed by federal law, it is possible that such behavior in the private sector could result in higher drug prices, with potential impact on pharmacy costs to the Medicaid program.

AGENCIES CONTACTED:

Insurance Department, Department of Administrative Services, and Department of Health and Human Services